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Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01660152
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
22.5
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine which technique in using a vacuum erection device (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern for both the surgeon and the patient. Recent studies have shown that beginning to use the vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile shrinkage. This is a potential issue that can occur because of decreased blood flow after prostate cancer surgery. This study will allow researchers to determine and compare vacuum therapy techniques and erectile function outcomes of patients who have prostate cancer surgery

Condition or Disease Intervention/Treatment Phase
  • Other: Sexual Health Inventory for Men (SHIM) questionnaire administration
  • Procedure: management of therapy complications
  • Procedure: Daily vacuum therapy
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Determine sexual function and penile morphometric outcomes for the post-robotic-assisted laparoscopic prostatectomy (RALP) patients undergoing daily vacuum therapy using one of two randomized methods and whether these outcomes differ.
SECONDARY OBJECTIVES:

  1. Compare compliance rates between the two randomized groups using the compliance questionnaire and a diary collected from patients at each follow up visit.

  2. Compare overall patient satisfaction with the recovery procedure between the two randomized groups utilizing the SHIM (Sexual Health Inventory for Men) questionnaire.

OUTLINE: Patients are randomized to 1 of 2 treatment groups.

GROUP A: Patients receive vacuum therapy daily over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times.

GROUP B: Patients receive vacuum therapy daily over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.

After completion of study treatment, patients are followed up at 3, 6, and 12 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Analysis of Technique Comparison With a Vacuum Erection Device as Part of an Erectile Rehabilitation Program Following Robotic Radical Prostatectomy: A Randomized Comparison of Methodology
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Jul 17, 2013
Actual Study Completion Date :
Jul 17, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (vacuum therapy, holding erection for 2 minutes)

Patients receive daily vacuum therapy over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

Other: Sexual Health Inventory for Men (SHIM) questionnaire administration
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
Other Names:
  • assessment

    • Procedure: management of therapy complications
    Receive VED
    Other Names:
  • complications of therapy, management of

    • Procedure: Daily vacuum therapy
    Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.
    Experimental: Group B (vacuum therapy, holding erection for 5 minutes)

    Patients receive daily vacuum therapy over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.

    Other: Sexual Health Inventory for Men (SHIM) questionnaire administration
    Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
    Other Names:
  • assessment

    • Procedure: management of therapy complications
    Receive VED
    Other Names:
  • complications of therapy, management of

    • Procedure: Daily vacuum therapy
    Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.

    Outcome Measures

    Primary Outcome Measures

    1. Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest [3 months post-surgery]

      Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.

    2. Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest [6 months post-surgery]

      Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.

    3. Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest [12 months post-surgery]

      Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.

    Secondary Outcome Measures

    1. Compliance and overall patient satisfaction (1 to 25 point scale) based on the self reported compliance diary and SHIM questionnaires [Up to 12 months post-surgery]

      Summarized according to assigned treatment group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Sexually active men without the consistent use of erectile aids pre-operatively (i.e. oral pharmacotherapy, intraurethral prostoglandin E1 [PGE1], intracavernosal injection therapy and penile implants)

    • Undergoing a bilateral nerve sparing robotic prostatectomy

    • Pre-operative baseline SHIM total score of greater than or equal to 17

    • Presence of a female sexual partner

    • Dexterity necessary to operate vacuum pump

    Exclusion Criteria:

    • Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months

    • Has taken or has been prescribed nitrate medication in any form in the last 6 months

    • Has a known sensitivity to Phosphodiesterase type 5 inhibitors such as Sildenafil, Tadalafil or Vardenafil

    • Men with sickle cell anemia

    • Men with insufficient manual dexterity to operate vacuum device

    • Men with a history of known penile deformity or Peyronie's disease

    • Pre or postoperative androgen therapy

    • Pre or postoperative radiation therapy to pelvic area

    • Men actively smoking at time of enrollment, 1 pack per day or more

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Ronney Abaza, MD, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01660152
    Other Study ID Numbers:
    • OSU-11019
    • NCI-2012-00997
    First Posted:
    Aug 8, 2012
    Last Update Posted:
    Apr 13, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Ohio State University Comprehensive Cancer Center
    male erectile disorder
    prostate cancer
    Laparoscopic prostatectomy
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Erectile Dysfunction

    Study Results

    No Results Posted as of Apr 13, 2017